AUDIT
Pre-FDA Inspection
As a medical device manufacturer, it is crucial to passing an FDA audit to maintain market access in the United States. For startups, it can be as nerve-racking as the first submitted 510(K). If you suspect issues within processes in your company but you are not certain these concerns are warranted, you can decide to perform a mock FDA audit by a third party.
Our consultants are experts and can perform a truly independent pre-FDA audit and assist you with; design control, quality management systems, management responsibility, process control, validation, maintenance etc. We will recommend practical solutions to enable your organization to come into full compliance in the most efficient and cost-effective way possible.